FDA Issues Warning About Test Strips That Can Give False Readings, Lead to Insulin Overdoses

The U.S. Food and Drug Administration has issued a warning against the use of GDH-PQQ blood glucose test strips by people with diabetes who are taking medications that contain non-glucose sugars. [Note: GDH-PQQ is the abbreviation of “glucose dehydrogenase pyrroloquinoline quinone,” a chemical that reacts with the non-glucose sugars maltose, galactose, and xylose, which are contained in some therapeutic products.]

Because the strips can mistake non-glucose sugars for glucose, they can give an inaccurately high BG reading that could lead to an insulin overdose.

The FDA warning is based on 13 deaths between 1997 and 2009 that were reported in healthcare facilities where patients were using the test strips. People with diabetes who are at highest risk are those undergoing dialysis or recovering from recent surgery.

According to the FDA alert, “Non-glucose sugars contained in some therapeutic products, such as peritoneal dialysis solutions and certain immunoglobulins, can falsely elevate glucose results, which may prompt excessive insulin administration. These therapeutic products, which are labeled to indicate that they may interfere with this particular glucose monitoring technology, are mostly used in patients with serious medical conditions, including kidney failure and moderate to severe rheumatoid arthritis.”

Smiths Medical

Insulet

Abbott Diabetes Care Freestyle test strips, for use with:

OmniPod Insulin Management System

The FDA notes that test strips may be distributed under multiple trade names. Because manufacturers of GDH-PQQ test strips currently on the market may subsequently change to non-GDH-PQQ methodology, the FDA recommends that healthcare providers and patients refer to the labeling on their test devices or consult with test strip manufacturers to confirm the type of BG measuring methodology they use.

Arkray stated “The GLUCOCARD 01 and Assure families of products use a glucose-specific enzyme and can, therefore, distinguish between glucose and other sugars. In light of the FDA’s announcement, ARKRAY will upgrade any consumer concerned about their GDH system to a product from the GLUCOCARD 01 family at no charge.”

Diabetes Health Medical Disclaimer

The information on this site is not intended or implied to be a substitute for professional medical advice, diagnosis or treatment. All content, including text, graphics, images, and information, contained on or available through this website is for general information purposes only. Opinions expressed here are the opinions of writers, contributors, and commentators, and are not necessarily those of Diabetes Health. Never disregard professional medical advice or delay seeking medical treatment because of something you have read on or accessed through this website.